The FDA has approved Omlyclo as the first interchangeable biosimilar to Xolair (omalizumab). This new medication will provide an alternative treatment option for multiple allergic and inflammatory conditions.

Omlyclo is approved for four key indications: moderate to severe persistent asthma in patients greater than 6 years of age whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids, with testing performed to check for allergies to year-round allergens; chronic rhinosinusitis with nasal polyps in patients greater than 18 years of age with inadequate response to nasal corticosteroids when used as add-on maintenance treatment; food allergy in patients 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which they are allergic (patients should continue to avoid all foods to which they are allergic); and chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria [CIU], chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment.

The medication functions by binding to immunoglobulin E, blocking it from binding to receptors that trigger allergic reactions. It is administered via subcutaneous injection with dosing regimens that vary by indication.

Health care providers should note that Omlyclo carries a boxed warning for anaphylaxis, which can occur after the first dose or after multiple doses, either immediately following injection or days later. Due to this risk, treatment should only be initiated in healthcare settings equipped to manage anaphylactic reactions.

Common side effects include injection site reactions, fever, headache, dizziness, and arthralgia.

The approval was granted to Celltrion. Omlyclo is not indicated for acute bronchospasm, status asthmaticus, emergency treatment of allergic reactions including anaphylaxis, or other forms of urticaria.

For more information about biosimilar products, including educational materials for healthcare providers and patients, visit www.fda.gov/biosimilars. Full prescribing information for Omlyclo is also available.